Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 3:40 PM
Ignite Modification Date: 2025-12-25 @ 1:50 PM
NCT ID: NCT03672292
Description: None
Frequency Threshold: 5
Time Frame: Through study completion, an average of 19 weeks
Study: NCT03672292
Study Brief: Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SCY-078 Plus Voriconazole Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards). PLUS Oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards). Treatment duration = minimum 6 weeks/Max 13 weeks SCY-078: Oral tablets of SCY-078 Voriconazole: Voriconazole IV vials or oral tablets 3 None 6 10 10 10 View
Voriconazole Mono-therapy Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards). PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given QD from Day 3 onwards). Treatment duration = minimum 6 weeks/Max 13 weeks Voriconazole: Voriconazole IV vials or oral tablets Oral Placebo Tablets: Oral Placebo Tablets matching SCY-078 1 None 5 12 11 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders Adverse Event View
Febrile Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders All Adverse Event View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders All Adverse Event View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders All Adverse Event View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Acute graft versus host disease in skin SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.0 View
Graft versus host disease in gastrointestinal tract SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.0 View
Haemophagocytic lymphohistiocytosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.0 View
Heart transplant rejection SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.0 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Enterobacter bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Enterococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Haemolysis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Thrombocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 26.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 26.0 View
Adrenal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 26.0 View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26.0 View
Eye haematoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26.0 View
Eye haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26.0 View
Photopsia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26.0 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26.0 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 26.0 View
Abdominal mass SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Anal fissure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Angular cheilitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Oral blood blister SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 26.0 View
Terminal ileitis SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Toothache SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Vomiting SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Disease progression SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 26.0 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Hypertransaminasaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 26.0 View
Acute graft versus host disease in liver SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.0 View
Acute graft versus host disease in skin SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.0 View
Graft versus host disease in gastrointestinal tract SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.0 View
Graft versus host disease in liver SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.0 View
Graft versus host disease in skin SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.0 View
Haemophagocytic lymphohistiocytosis SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.0 View
Heart transplant rejection SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 26.0 View
Blastocystis infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Cytomegalovirus infection reactivation SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Enterobacter bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Enterococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Enterococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Enterococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Oral herpes SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Streptococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Toxicity to Various Agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Drug level decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Ejection fraction decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 26.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hypervolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Hypovolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Vitamin D deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 26.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Axillary mass SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Tendon disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 26.0 View
Anosmia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Disturbance in attention SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Restless legs syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Hallucination SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Urethral pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Acute pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Sputum discoloured SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Stridor SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Decubitus ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Dermatitis acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Night sweats SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Photosensitivity reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Skin mass SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26.0 View
Blood cholesterol SYSTEMATIC_ASSESSMENT Investigations All Adverse Event View